Milrinone Infusion for VAsospam Treatment in Subarachnoid hemoRrhage

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Subarachnoid hemorrhage (SAH) is a frequent and severe disease. Mortality can reach 40%. The most frequent complication of SAH is arterial vasospasm, with estimated incidence as high as 70%. Vasospasm is responsible for cerebral ischemia leading to severe morbidity, poorer quality of life and increased mortality.

Intravenous Milrinone, because of vasodilatory properties could be a therapeutic option. We hypothesize that intravenous infusion of Milrinone will improve the neurological recovery of patients with vasospasm following aneurysmal SAH at 3 months.

This is a Phase III, multi-center, randomized, double-blinded, placebo-controlled study. The primary outcome will be the proportion of patients with a good outcome 3 months (defined as a modified rankin score ≤2).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Angers
• Treatments: Milrinone; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Adult patients hospitalized for aneurysmal SAH

• First episode of vasospasm, with a diagnosis confirmed on cerebral arterial CT-scanner

• Delay between diagnosis of vasospasm (i.e. CT-scanner) and inclusion ≤6 hours

Exclusion Criteria:

• Initial Glasgow score at 3 with a bilateral mydriasis

• Moribund patient

• Pregnant woman

• Contraindication to Milrinone (obstructive cardiomyopathy…)

• Cerebral infarction in the vasospasm area already present on the CT-scanner at the time of diagnosis (lack of expected benefit of treatment in this case- according to medical judgement)

• Non-affiliation to French health care coverage,

• Adult patient protected under the law (guardianship)

• Cardiac failure necessitating inotropic agents

• Uncontrolled Intracranial hypertension (ICP>25 mmHg for more than 20 min)

• Inclusion in an interventional study using Milrinone, or evaluating a treatment of cerebral vasospasm or with the same primary endpoint (mRS at 3 months).